Plaque Registration and Event Detection In Computed Tomography (PREDICT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2013 by Hiroshima University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Yasuki Kihara, Hiroshima University

ClinicalTrials.gov Identifier:

NCT00991835

First received: October 7, 2009

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Purpose

Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.

Condition
Atherosclerosis Cardiovascular Diseases Coronary Artery Disease


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography

Resource links provided by NLM:

MedlinePlus related topics: CT Scans

U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:

Major cardiac events (Cardiac death and acute coronary syndrome) [ Time Frame: 2 years after the CT-scan ] [ Designated as safety issue: No ]
All-cause death [ Time Frame: 2 years after the CT-scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations) [ Time Frame: 2 years after CT-scan ] [ Designated as safety issue: No ]
All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure) [ Time Frame: 2 years after the CT-scan ] [ Designated as safety issue: No ]

Other Outcome Measures:

Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics [ Time Frame: 2 years after CT ] [ Designated as safety issue: No ]


Enrollment:	3015
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2014
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients reffered to cardiovascular hospital

Criteria

Inclusion Criteria:

patients with known or suspected coronary artery disease.

Exclusion Criteria:

irregular heart beat,
known allergy towards the contrast agent,
renal dysfunction,
uncontrolled heart failure,
previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
impossible breath-hold, OR
end-stage cancer.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00991835

Locations


Japan
Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine
Hiroshima, Japan, 734-8551

Sponsors and Collaborators

Hiroshima University

Investigators


Study Chair:	Yasuki Kihara, MD,PhD	Hiroshima University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yamamoto H, Awai K, Kuribayashi S, Kihara Y; PREDICT Investigators. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):90-6. doi: 10.1016/j.jcct.2013.12.004. Epub 2014 Jan 8.


Responsible Party:	Yasuki Kihara, Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences, Hiroshima University
ClinicalTrials.gov Identifier:	NCT00991835 History of Changes
Other Study ID Numbers:	PREDICT2009
Study First Received:	October 7, 2009
Last Updated:	March 18, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:


Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Atherosclerosis	Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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